The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 12 hours of CE credit.

This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP). Participants will acquire real-world application of GCP regulations and guidelines for critical elements of the clinical research and development process. This training includes the updates brought by the ICH E6 R2 Addendum.

During this interactive workshop, we will debate in what way clinical research team members can apply systems to achieve data integrity and quality through the trial lifecycle.

Specific attention will be given to how quality systems affect overall data integrity, patient clinical risk, and respective regulatory risk.

Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of protocols

The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation; maintenance

GCP Across Investigational Products: Drugs; devices; biologics

Are We There Yet? Recent non-compliance issues with discussion of Corrective and Preventive Action planning

Who will Benefit:

This program is designed for professionals with two to three years of experience in the clinical research industry. Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP Focused Regulatory Affairs Professionals.

Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP), which he founded, helping pharmaceutical companies & academic institutions worldwide to achieve compliance with GCP, GVP, GCLP, GDP and GLP.

Amer, a Clinical pharmacologist by education, has over 28 years’ experience in the pharmaceutical industry. He enjoys imparting his experiences, as an invited speaker at over 125 international congresses and as writer; he published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Amer has experience of working at the MHRA where he participated in the conduct of the very first Regulatory Authority pharmacovigilance-GCP inspection in the EU and wrote the 1st EU regulatory authority SOPs on conducting GVP inspections. He has over 21 years’ experience of directing Inspection Readiness Programs (Mock Inspections & Pre- & Post-Mock Inspection-Training) and hosting regulatory authorities’ & notified bodies’ inspections. To date, he has prepared, trained, hosted & managed over 67 Regulatory Authorities’ inspections by all major regulatory authorities (FDA, EMA, EU Authorities (CAs), Japanese PMDA, Brazilian, Chinese SFDA & Middle Eastern authorities etc.) Earlier in his career, he was Assistant Editor for 11 medical journals and was the 1st invited Course Director for The Pharmacovigilance Auditing Course at the RQA.

Amer’s other previous positions included: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. Boston, USA, Global Director, Head of Quality Assurance at Merck Serono, Geneva, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

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